tbuckley/cabot-search huggingface dataset:
The implementation of a diverse clinical trial program at a rural community cancer center over a 10-year period.
Authors: John Stewart Hrom, Christopher Sentell, Gloria Simmons, Juliet Hinton
Journal: Journal of Clinical Oncology (2023)

e18559 Background: The state of Mississippi ranks last or close to last in the majority of health outcomes including cancer outcomes due to health disparities. Health disparities are worse for patients who face obstacles due to race, socio-economic status, or geographical exclusion. Improving minority enrollment in clinical trials allows for improved cancer care. We report the implementation of an inclusive and diverse clinical trial program at a community cancer center in rural Mississippi over a 10-year period of time. Forrest General Cancer Center cares for patients in a 19 county area with a diverse patient population consisting of 72.8% White, 25.8% Black, and 1.4% Other. Methods: We reviewed the patient database of our clinical trial program over a 10-year period of time from January 1, 2013, through December 31, 2022. All patients enrolled on clinical trials during this period were included in our analysis. We collected data regarding types of clinical trials, racial demographics, patient age, and primary sight of malignancy. A two proportion Z-test was utilized to analyze any differences between race in the study group and cancer population as a whole. A 2 tailed P value was then calculated. Results: During the 10-year period, 242 patients successfully enrolled onto clinical trials. 227 (93.80%) patients were enrolled on interventional treatment studies, and 15 (6.19%) patients were enrolled on registration studies. 233 (96.28%) patients were enrolled on pharmaceutical sponsored trials as opposed to 9 (3.72%) patients enrolled on cooperative group trials. 180 (74.4%) patients were White, 62 (25.6%) patients were identified as minority patients including 60 (24.8%) Black patients, and 2 (0.8%) Asian patients. There was no statistical difference between the racial diversity of study patients compared to baseline patient demographics (P = 0.608318). The average age of enrollment was 61.85 years (range 24-89). The average age for White patients was 63.06 years, and the average age for Black patients was 57.77 years. The most common malignancies included Breast 91 (37.6%), Lung 63 (26.0%), Hematolymphoid 41 (16.9%), Colon 16 (6.6%), Head and Neck 10 (4.1%), and Melanoma 5 (2.1%). Conclusions: We have demonstrated the successful implementation of an Oncology clinical trial program in rural Mississippi leading to advanced patient care with increased availability to high-quality clinical trials. During this time period, we have successfully enrolled a diverse population accurately representing our patients under our care. We feel that our model can successfully be implemented at cancer centers caring for underserved and minority patients throughout the United States leading to improved patient care in these populations. We have shown that it is possible to have a successful clinical trial program with primarily industry sponsored clinical trials in a community cancer center.
Development of a palliative care lecture series for hematology-oncology fellows.
Authors: Rachel Rodenbach, Sam Joseph Lubner, Sara Johnson
Journal: Journal of Clinical Oncology (2023)

e24112 Background: Many major organizations endorse provision of palliative care (PC) services for patients with advanced cancers from both oncologists and PC specialists. While ACGME has outlined core PC competencies, PC education during hematology-oncology (HO) fellowship is highly variable, and many fellows feel inadequately trained. We assessed whether incorporation of a PC lecture series could improve fellows’ self-perceived preparedness in basic PC skills. Methods: In this educational quality improvement initiative, current HO fellows at an NCI-designated cancer center received lectures on PC topics. Members of both the HO and hospice and palliative medicine fellowship programs met to discuss key components of a PC curriculum and identify available experts. Seven multidisciplinary faculty members delivered eight one-hour video-recorded virtual lectures to HO fellows over a three-month period. Lecture videos remained available online for later viewing in the event of fellow absences. Within a few weeks both pre- and post-lecture series, HO fellows completed surveys addressing their level of preparedness on a 5-point scale (from 1-not at all prepared to 5-extremely prepared) in performing several key skills. Two-tailed paired t-tests were performed to analyze pre/post changes in fellows’ level of preparedness. Results: Eleven fellows participated in the PC lecture series. Fellows’ level of preparedness increased across several PC topics (Table). The greatest increases were in creating a survivorship plan, converting from one opioid to another, and managing pain in a patient at risk for a substance use disorder. Fellows ranked individual lectures as very helpful to their learning, especially lectures on management of GI symptoms (4.9 +/- 0.3), pain management with opioids (4.8 +/- 0.4), and communication (4.5 +/- 0.5). Conclusions: Incorporation of a structured PC didactics series into HO fellowship is feasible, perceived as very useful, and associated with increased self-perceived preparedness. While more longitudinal and hands-on PC experience would likely promote HO fellows’ PC skills more deeply and durably, dedicated PC lectures are an important adjunctive component that can be easily incorporated into HO fellowship education. [Table: see text]
Two-year lung cancer survival between 2000 to 2020: Results from 3 French nationwide cohorts.
Authors: Didier Debieuvre, Isabelle Monnet, Olivier Bylicki, Sophie Schneider, Francois Goupil, Benoit Godbert, Christine Dussopt, Herve Pegliasco, Laurent Portel, Reda Chikouche, Philippe Masson, Mohamad Jaafar, Clothilde Marty, Fethi EL Khanjari, Julie Obert, Marjorie Picaud, Anne Sophie Bravard, Herve Le Floch, Alexia Letierce, Hugues Morel
Journal: Journal of Clinical Oncology (2023)

8542 Background: Each decade since 2000, the French College of General Hospital Pulmonologists (CPHG) conducts the KBP study, a real-life nationwide prospective multicenter study on LC in non-academic public hospital (NPH). Here, we report the two-year survival (2-y) rate among the 2020 cohort and the comparisons with the 2000 and 2010 cohorts. Methods: Collection of all consecutive diagnosed LC, all stage and all histology, between 01/01 and 12/31 in NPH pulmonology or oncology units in 2000, 2010 and 2020 with the same methodology. A Scientific Committee controlled inclusion exhaustivity and quality in each center. Survival rates were calculated using the Kaplan-Meier method and risk factors were assessed using Cox models. Results: 8,999 patients were included in 82 centers in 2020. The 2-y survival rate was 40.3%, the median overall survival was 15.3 months. Compared to 2000, mortality rates at 2 years decreased significantly (-19.1%), while early (1 month and 3 months) mortality remains similar. Survival improved in 20 years whatever histologic types (Table). Factors associated with 2-y survival were sex (36.1% vs 48.1% respectively for male and female respectively, significantly increased over 20 years: + 15.3% for M and + 24.5% for F), high age (&gt;80 y-o), poor ECOG status (3 or 4) and advanced disease. As expected in 2020, TNM stage was still determining for 2-year mortality, 15.2 [12.6-17.7] stage I vs 75.6 [74.4-76.8] stage IV. In 2020 the Covid-19 infection (n=283) impacted the survival (HR = 4.02 95%CI [3.33-4.86]) on multivariate analysis adjusted to age, sex, tobacco consumption, histology, ECOG status, TNM stage. Conclusions: These results confirmed the major improvement in the last two decades for LC. 5-years survival will provide us more enlightenment. [Table: see text]
Oncology financial advocacy services guidelines: Results of a Delphi study.
Authors: Leigh Boehmer, Rifeta Kajdic Hodzic, Allison Harvey, Meredith Doherty, Sharon Gentry, Rebecca A Kirch, Krista Nelson, Christina Mangir, Angie Santiago, Lori Schneider, Elana Plotkin
Journal: Journal of Clinical Oncology (2023)

e18606 Background: At least half of people with cancer experience financial toxicity1 but financial advocacy has emerged as a promising intervention to mitigate it. How cancer programs and practices screen for financial toxicity among patients and the types of services they offer vary greatly. Standardization is needed to evaluate the outcomes and impacts of financial advocacy. Therefore, the Association of Community Cancer Centers (ACCC) Financial Advocacy Network set out to develop Oncology Financial Advocacy Services Guidelines (hereafter “the Guidelines”) to address this gap. Methods: To conduct this original, non-clinical trial research, ACCC convened a task force of seven multidisciplinary experts in financial advocacy to oversee a modified Delphi study. The task force assembled a panel of 49 experts, who represented oncology financial advocacy staff, multidisciplinary cancer care team members, financial advocacy subject matter experts, as well as patients and patient advocates. Based on a literature review and qualitative input from panelists, the task force drafted a list of 44 potential guidelines. In early 2022, panelists completed two rounds of anonymous voting, determining if each statement should not be a guideline, be a minimum guideline, or be an enhanced guideline. Consensus was set at 75% agreement. Results: The panel reached consensus that 43 statements should be guidelines. One guideline was rated minimum, while another 17 trended toward being considered minimum (60%-74% agreement among panelists). The panel rated one guideline as enhanced, with two others trending toward being enhanced. Twenty-two guidelines did not reach consensus one way or another on being minimal vs. enhanced. Conclusions: The Guidelines are publicly available in a report that includes implementation considerations extracted from Delphi panelists’ comments and task force input. Half of guidelines did not reach consensus on whether they are minimum or enhanced, reflecting the diversity of current financial advocacy practice and a need to develop greater standardization in the field. ACCC is taking several next steps to advance research and quality practice using the Guidelines, including collaborative policy development, assessment tools, and the creation of valid metrics and accountability measures.
In hospital outcomes and mortality predictors of multiple myeloma on stroke hospitalizations: A multivariable logistic regression study on the National Inpatient Sample Database.
Authors: Zunairah Shah, Hafiz Muhammad Waqar Younas, Mohammad Ebad Ur Rehman, Amro Taha, Ali Shahbaz Shehbaz Baloch, Fadi Khir, Irisha Badu, Jawad Basit, Harigopal Sandhyavenu, Shehzad Ali, Faiz Anwer
Journal: Journal of Clinical Oncology (2023)

e20048 Background: Multiple Myeloma (MM) patients have a higher risk of stroke due to a hypercoagulable state. A study by Liu et al. 2014 reported a 1.23 times higher incidence of stroke in MM patients compared to the matched cohort. Another study by Lee et al. 2016 reported a 5-year estimated cumulative incidence rate of 7.45%. Bortezomib therapy is an independent risk factor for stroke. However, data on the inpatient outcomes of MM on stroke hospitalizations is limited. Therefore, we conducted a nationwide population-based study investigating in-hospital outcomes and mortality predictors of MM in stroke hospitalizations. Methods: The national inpatient sample database from 2016-2019 was queried to identify patients with a primary diagnosis of stroke and stratified based on the presence of MM as a secondary diagnosis. The adjusted odds ratios (aOR) of in-hospital outcomes were calculated using multivariable logistic regression using STATA v.17 software. The primary outcome was in-hospital mortality. Results: A total of 2,028,240 weighted hospitalizations with stroke were identified between 2016-2019, of which 4,240 were associated with MM. On adjusted analysis, stroke-MM patients have statistically significant higher odds of in-hospital mortality (aOR 1.33, CI 1.01-1.40, P&lt;0.001). Furthermore, the presence of fluid and electrolyte imbalance, complicated diabetes mellitus, and coagulopathy were found to be independent predictors of mortality. However, the odds of major adverse cardiovascular events (MACE), acute myocardial infarction (AMI), and cardiac arrest were similar between stroke patients with and without MM. Bleeding risk was not assessed, given the low sample size. Additionally, no significant statistical difference was found between the two cohorts regarding the length of hospital stay and cost of hospital stay. Conclusions: Stroke patients with MM have significantly higher odds of in-hospital mortality than those without MM. Given the increased mortality risk, physicians should pay particular attention to optimizing the modifiable risk factors of stroke. Large-scale prospective trials are needed to identify the patients at the highest risk. [Table: see text]
Real-world (RW) dosing patterns and outcomes among chronic lymphocytic leukemia (CLL) patients (pts) with or without an ibrutinib (IBR) dose adjustment (DA) in first-line (1L).
Authors: Kerry Anne Rogers, Xiaoxiao Lu, Bruno Emond, Zhijie Ding, Patrick Lefebvre, Marie-Hélène Lafeuille, Heena Mavani, Zaina P. Qureshi, Nilanjan Ghosh
Journal: Journal of Clinical Oncology (2023)

7537 Background: Pts treated for CLL with IBR, a once-daily Bruton’s tyrosine kinase inhibitor with dosing flexibility options, may adjust their daily dose to help prevent recurrence or worsening of adverse events, while preserving efficacy. This RW study describes outcomes for CLL pts treated with 1L IBR who did or did not have a DA. Methods: Electronic medical records from the Acentrus database (1/1/2016-4/30/2022) were used to identify CLL pts initiated on 1L IBR (index date). The first 6 months post-index were used to identify pts who remained on a starting dose of 420mg/day or with a DA (reducing to a dose lower than 420mg/day; reasons for DA not available). Treatment adherence (measured by proportion of days covered [PDC] and medication possession ratio [MPR]) and time to next treatment (TTNT) were described for patients with and without a DA. Descriptive analyses are reported for all pts and among a subgroup of pts with high cardiovascular (CV) risk, defined as having a pre-existing CV comorbidity or a high CV risk score (CV subgroup). Results: 1,171 CLL patients were initiated on 1L IBR at the recommended dose of 420mg/day (Table). Of those, 1,038 (88.6%) remained on 420 mg for ≥6 months (mean age=70.2 years, 33.6% female, median follow-up: 30.5 months); 229 (19.6%) had a DA at any time post-index (median time to DA: 5.5 months) and 126 had the DA during the first 6 months (mean age=72.2 years, 42.9% female, median follow-up: 35.1 months). Mean PDC and MPR were descriptively higher in pts with a DA (overall: PDC=0.81, MPR=0.84; CV subgroup: PDC=0.78, MPR=0.81) relative to pts with no DA (overall: PDC=0.70, MPR=0.73; CV subgroup: PDC=0.69, MPR=0.72). Median TTNT was not reached for pts with or without a DA; 12-month Kaplan-Meier (KM) rates were similar for pts with a DA (overall: 89.1%; CV subgroup: 92.7%) and with no DA (overall: 92.5%; CV subgroup: 92.0%). Conclusions: Among CLL pts initiating 1L with standard-of-care IBR, 19.6% had a DA. Those with a DA had descriptively higher treatment adherence with no detriment to TTNT, relative to those who maintained 420mg/day starting dose, regardless of baseline CV risk. These findings are consistent with other RW studies and suggest that IBR DA can be an effective treatment strategy that does not negatively affect efficacy while being well-tolerated outside of clinical trials. [Table: see text]
Palliative care consultation and end-of-life outcomes in a retrospective cohort of patients treated with immune checkpoint inhibitors.
Authors: Chance H. Bloomer, Andrew T. Faucheux, Alexander M. Quattlebaum, Catherine A. Elko, John Hunting, Lara M. Khoury, Eric Olson, Rebecca Omlor, Thomas William Lycan
Journal: Journal of Clinical Oncology (2023)

6577 Background: Immune checkpoint inhibitors (ICI) can prolong survival for various cancers and are generally available as treatment options for most patients because of their favorable adverse effect profile. Although ICIs provide treatment for many patients who would otherwise be out of options, their variable and often delayed efficacy may postpone the de-escalation of care at the end of life. Palliative Care consultation (PCC) is well-established among patients receiving cytotoxic chemotherapy, but its effectiveness is less certain among patients receiving newer treatment modalities. We aimed to test the association of PCC with end-of-life (EOL) outcomes among patients treated with an ICI for any type of cancer. Methods: We created a retrospective registry of all patients who received at least one dose of ICI for any indication between 2/1/2011 and 4/7/2022 at a comprehensive cancer center and its outreach clinics. The investigators created a secure, cloud-based registry (REDCap), validated it with data quality rules, and resolved all discrepancies; clinical research specialists at Vasta Global captured most of the data. We used the chi-square test to compare categorical variables, defined statistical significance as p &lt; 0.05, and used SAS version 9.4 for analyses. The study had institutional IRB approval. Results: The cohort consisted of 3,142 patients with lung cancer (45%) as the most common cancer type, followed by melanoma (14%) and head and neck squamous cell carcinoma (9%). ICI was most often given in the first line setting (46%) with good baseline performance status (ECOG 0-1, 50%). 915 (29%) patients had PCC, which was associated with a higher rate of code status de-escalation from “Full Code” at any point before death (92% vs. 87%, p 0.007). There was no association between PCC and either the initiation of ICI within 30 days of death (7% vs. 5%, p .0172) or any dose of ICI within 14 days of death (5% vs. 6%, p 0.33). Among patients with a confirmed location of death (1013, 32%), PCC was associated with a similar rate of death in the hospital at any level of care (30% vs. 28%, p 0.51). Conclusions: PCC was associated with code status de-escalation before death but similar risks of late ICI dosing or inpatient status at the time of death. Further studies are needed to risk-stratify patients starting ICI to identify the subgroups that would benefit the most from PCC.
Long-term safety with ≥12 months of pirtobrutinib in relapsed/refractory (R/R) B-cell malignancies.
Authors: Catherine Callaghan Coombs, Nirav Niranjan Shah, Wojciech Jurczak, Jennifer Ann Woyach, Chan Cheah, Krish Patel, Kami J. Maddocks, Yucai Wang, Catherine E. Muehlenbein, Chunxiao Wang, Sarang Abhyankar, Donald Edward Tsai, Toby A. Eyre
Journal: Journal of Clinical Oncology (2023)

7513 Background: While Bruton tyrosine kinase inhibitors (BTKi) can induce sustained remissions, ongoing response requires continuous treatment and thus long-term safety/tolerability is critical for adherence, maintaining dose intensity, and delivering maximum efficacy. Pirtobrutinib is a highly selective, non-covalent (reversible) BTKi approved by the FDA in January 2023 for R/R mantle cell lymphoma after 2 prior lines of therapy including a BTKi. Pirtobrutinib has demonstrated promising efficacy with low discontinuation and dose reduction rates in patients (pts) with multiple subtypes of R/R B-cell malignancies. However, the long-term safety and tolerability of pirtobrutinib has not yet been reported. Here we report the clinical safety in pts with long-term (≥12 months) pirtobrutinib treatment from the phase 1/2 BRUIN trial. Methods: Pts with R/R B-cell malignancies who received ≥12 months of pirtobrutinib were included. Median time to onset, dose reduction, discontinuation, and cumulative incidence rates were determined for treatment emergent adverse event (TEAE) that occurred in ≥20% of pts and select AE of interest associated with BTKi. Results: As of 29 July 2022, 773 pts were enrolled, and 326 (42%) pts received treatment for ≥12 months. Among these 326 pts, median time on treatment was 19 months (IQR: 16,25), with 231 (71%) remaining on pirtobrutinib. The most common TEAE (all grade, regardless of attribution) in this long-term 326 pt cohort were fatigue (32%), diarrhea (31%), Covid-19 (29%), contusion (26%), cough (25%), and back pain (21%). TEAE leading to dose reduction or discontinuation occurred in 23 (7%) and 11 (3%) pts, respectively. Four (1%) pts discontinued due to a treatment-related AE, and 1 pt had a fatal treatment-related AE (Covid-19 pneumonia). Select AE of interest for the long-term pts are shown in the Table. Comprehensive safety analyses describing the frequency of TEAE over time will be presented. Conclusions: Prolonged pirtobrutinib therapy continues to demonstrate a safety profile amenable to long-term administration at the recommended dose without evidence of new or worsening toxicity signals. The safety and tolerability observed in pts on therapy for ≥12 months was similar to previously published safety analyses on all pts enrolled regardless of follow-up. Clinical trial information: NCT03740529 . [Table: see text]